SK Biopharmaceuticals, a South Korean pharmaceutical company, announced today that the first patient was dosed in a phase 2 clinical trial in the US for patients suffering with chronic constipation using their new chemical entity YKP10811. The goal of this program is to develop a drug with once-a-day oral dosing and improved efficacy and safety for the treatment of chronic constipation and other disorders related to reduced gastrointestinal (GI) motility. Recently, SK Biopharmaceuticals successfully completed their Phase 1 trials in the US.

Chronic constipation is a very common gastrointestinal disorder with a prevalence of up to 20% in the developed world. Patients with chronic constipation often experience infrequent bowel movements, hard stool and straining during defecation. The current treatment for constipation relies on dietary fiber supplements, laxatives and intestinal fluid secretagogues.

Unlike these currently-available treatment options, YKP10811 is believed to possess a broad spectrum of efficacy in both the upper and lower GI tract and an improved safety profile.

Dr. Jeong Woo Cho, Vice President of the Drug Development Business for SK Biopharmaceuticals, said, "YKP10811 was shown to be safe in Phase 1 clinical studies in healthy volunteers. In particular, at the highest tested dose level of 1,350 mg, the drug did not show any significant signs of drowsiness or sedation."

Dr. Christopher Gallen, CEO of SK Biopharmaceuticals, stated, "We believe that safety is the key for compounds in this class, and the innovative approach our chemists have used in developing an exceptionally clean partial agonist has great potential to produce the preclinical and clinical profile essential for a safe and effective best-in-class medication."

If the Phase 2 clinical trials and coming Phase 3 trials are successful, it is expected that YKP10811 would be launched in 2016.

Dr. Cho also said, "Approximately 40 million Americans suffer from symptoms of abdominal pain and bloating as well the constipation that accompany chronic constipation or constipation-predominant Irritable Bowel Syndrome. At least 10 million of these patients are dissatisfied with the over-the-counter and prescription treatments that are currently available. If YKP10811 shows efficacy on the abdominal and constipation symptoms, the value of the drug will be tremendous."

There have been clear statements from regulatory bodies that have increased the pressure on pharmaceutical companies to go electronic with their records and ensure a high level of data integrity in all areas of the pharmaceutical industry.

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